Download guidance note on the new provisions on nitrites/nitrates in meat

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GUIDANCE NOTES ON THE
REVISED PROVISIONS ON
NITRITES/NITRATES IN MEAT PRODUCTS SET OUT IN THE
MISCELLANEOUS FOOD ADDITIVES AND SWEETENERS IN FOOD
(AMENDMENT) (ENGLAND) REGULATIONS 2007.
Status
This guidance represents the views of the Food Standards Agency. In
preparing it FSA has sought views from consumer, enforcement and industry
stakeholders. Enforcement of the legislation is the responsibility of local
authorities. Interpretation of the legislation is ultimately a matter for the
Courts.
Introduction
The notes in this section cover only those aspects of the above legislation that
are specific to the use of nitrites and nitrates in meat products. (E249
potassium nitrite, E250 sodium nitrite, E251 sodium nitrate and E252
potassium nitrate.)
The Miscellaneous Food Additives and the Sweeteners in Food (Amendment)
(England) Regulations 2007 (“the Regulations”), which implement European
Council and Parliament Directive 2006/52/EC amending Directive 95/2/EC for
the sixth time, came into force on 25 July 2007. (Similar legislation exists in
Scotland, Wales and NI). Food additives legislation can be accessed on the
European Commission's website at the following address:
http://www.europa.eu.int/comm/food/food/chemicalsafety/additives/index_en.htm
The legislation amends the existing provisions in Schedule 2 Part C of the
Miscellaneous Food Additives Regulations 1995 (as amended) to introduce a
reduction in the authorised levels for nitrites and nitrates in meat and other
food products, which takes account of the opinion of the European Food
Safety Authority (EFSA), published on 26 November 2003 and aims to keep
levels of nitrosamines as low as possible whilst maintaining the
microbiological safety of food products. In addition, in line with EFSA’s
recommendations, controls on the level of nitrites and nitrates in meat
products, are in future to usually be based on added rather than residual
amounts. However, during Brussels discussions on the legislation, Member
States recognised that a degree of compromise was required in order to
achieve the objective of further controls on the use of nitrates and nitrites in
most meat products, whilst allowing the continued production of certain
traditional products. These compromises, which include provisions which
permit traditional UK meat products such as Wiltshire cured ham, bacon and
similar products to be produced based on residual amounts, are contained
within the new legislation.
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The legislation includes transitional provisions permitting food containing
nitrites and nitrates that do not comply with the legislation to continue to be
marketed until 15 August 2008, provided these products comply with the
provisions in previous miscellaneous food additives legislation. In addition,
existing stocks which do not comply with the Regulations and which have
been placed on the market or labelled before 15 August 2008, can be
marketed until they are exhausted. After this date, no new foods containing
nitrites/nitrates can be placed on the market unless they conform to the
requirements of the Miscellaneous Food Additives and the Sweeteners in
Food (Amendment) (England) Regulations 2007.
General structure of the legislation
Other than certain traditional products, the legislation limits the use of
potassium and sodium nitrite in meat products to a maximum amount added
of 150 mg/kg, and in sterilized meat products (Fo > 3), to 100 mg/kg. The use
of potassium and sodium nitrate is permitted only in non-heat-treated meat
products, to a maximum amount added of 150 mg/kg, although nitrates may
be present in some heat treated meat products resulting from natural
conversion of nitrites to nitrates in a low-acid environment. The limits for both
nitrites and nitrates relate to the maximum amount that may be added during
the manufacture of the product i.e. ingoing limits.
The traditional meat products for which derogations have been requested by
EU Member States, which include categories for six traditional UK meat
products, are listed in italics, which indicates they are Member States’ national
products. They are grouped under three headings:

traditional immersion cured meat products, including Wiltshire
bacon and Wiltshire ham and similar products and cured tongue;

traditional dry cured meat products, including dry cured bacon and
dry cured ham and similar products; and

other traditionally cured meat products, which includes jellied veal
and brisket.
For traditional products, the limits for both nitrites and nitrates relate to the
maximum residual levels permitted in finished products.
Footnotes in the legislation specify in detail the manufacturing method for
each of these traditional products. When interpreting the legislation, the
information in the footnotes for each specific product should be read in
conjunction with the general description for the type of product. For example,
to meet the specification for Wiltshire bacon, the product would need to
comply with:
 the description at footnote 1 for traditional immersion cured meat
products (i.e. it would need to be immersed in curing solution
containing nitrites and/or nitrates, salt and other components, and it
may also undergo further treatments e.g. smoking.); AND
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
the manufacturing process for Wiltshire bacon at footnote 1.1 (i.e. it
would need to be injected with curing solution followed by immersion
curing for 3 to 10 days. The immersion brine solution includes
microbiological starter cultures).
Traditional products which do not fit in to any named category
Only certain types of traditional products are specifically referred to in the
legislation. If a product does not meet the requirements for any named
product (allowing for “similar products” explained below), it then defaults to a
general category e.g. “meat product” or “non-heat-treated meat product” and
the maximum ingoing permitted levels should be used.
“Similar products”
The Directive contains the words “and similar products” against many, but not
all, of the categories for which derogations have been granted. The Directive
does not define similar products and currently there are no decisions by the
EU Standing Committee or by a Court. The overall intention of the legislation
is to reduce the use of nitrites and nitrates so the Council and European
Parliament saw the derogations for certain traditional products as being of a
limited nature, and the Parliament in particular wished to see the footnote
specifications which limit the named derogations. With this background, we
consider that a similar product:
- will closely resemble the product named (but may obviously have a different
name);
- has been traditionally produced;
- has been produced using the same stages as described in the footnotes,
though there may be some variation in the times and temperatures cited in the
footnotes.
To be 'traditionally produced' we consider a product needs to have been
produced for more than 25 years at the time EC Directive 2006/52 came into
force (ie since before September 1981). Traditional is not defined within EC
Directive 2006/52 and it is ultimately for a Court to decide the interpretation.
We have suggested it should be taken to be of the order of 1 generation / 25
years, which would be in line with Regulation (EC) No 509/2006 of 20 March
2006 on Agricultural Products and Foodstuffs as Traditional Specialities
Guaranteed, that introduced a legal definition of the term ”traditional”,
specifically for the purpose of the regulation. This definition requires a period
of 25 years for production/recipe for a traditional food that is registered under
the Scheme.
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Dry cured ham
The ‘dry cured ham’ produced in the UK, which is different to that produced
elsewhere in the EU, is defined by way of the manufacturing process at
footnote 2.1. The process used must comply with that stipulated in the
footnote; otherwise the product will default into the relevant general meat
product category.
Wiltshire bacon/ham
Whilst no definition of Wiltshire cure has been included in the legislation, the
manufacturing process for Wiltshire cured ham and bacon is defined in
footnote 1.1. The use of ‘live’ immersion brines is the main distinguishing
factor between Wiltshire and other cures.
Footnote 1.1 states that the immersion brine solution includes microbiological
starter cultures. We do not consider it is necessary for a culture to be added
prior to each immersion; the culture may well be present, as it traditionally
was, from previous use of the immersion solution.
Cure-in-the-bag products
Cure-in-the-bag products are injected with curing solution, and not immersed,
and it is possible to accurately regulate the ingoing amount of curing solution.
This type of product therefore falls under the general meat products category
and not in the derogations for traditional immersion cured meat products.
Non-heat-treated meat products
Sodium and potassium nitrates are permitted to be added to “non-heat treated
meat products”. In its proposal the European Commission considered that the
use of nitrate would not be necessary in products which have been heat
treated to the extent that any bacteria have been destroyed. It follows
therefore that the relevance of any heat treatment and the use of nitrates
needs to take into account the stage in which the heat treatment is applied
and the effectiveness of any heat treatment (temperature and time). For
example, a piece of bacon or ham is cooked before consumption (and
possibly before purchase); however such a heat treatment could not be
considered to negate the need for nitrates at the earlier stages of preparation.
Products that should be considered as “heat treated” include many products
which are cooked after canning.
If a non-heat treated meat product is used as an ingredient in a compound
product (which may also contain heat treated meat as a further ingredient),
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the presence of nitrate would be permitted in the compound product up to the
limit permitted for the non-heat treated product under the ‘carry over’ provision
for compound foods in the legislation.
Bacon, Filet de bacon
The entry for ‘Bacon, Filet de bacon’ refers to a traditional French product and
is not the same as standard bacon. Hence, the maximum permitted level (250
mg/kg residual, without added E249 or E250) only applies to this and similar
products.
Conversion factor for potassium salts
All levels given in the legislation are for the sodium salts. Conversion factors
for the equivalent potassium salts are:
To convert sodium nitrite to potassium nitrite: multiply by 1.23
To convert sodium nitrate to potassium nitrate: multiply by 1.19
For example the maximum amount of sodium nitrite which can be added to
sterilised meat products is 100 mg/kg, which is equivalent to 123 mg/kg
potassium nitrite. And the maximum amount of sodium nitrate which can be
added to non-heat treated meat products is 150 mg/kg, which is equivalent to
178 mg/kg potassium nitrate
Tolerance levels
We welcome comments from LACORS on this issue.
Nitrate Levels in Water Supply
We consider the amount of nitrate added as part of the manufacturing process
should take into account that naturally present in the water supply. This is
particularly relevant in areas with extremely high levels of nitrate in the water
supply.
Vegetable extract nitrates
The indirect addition of nitrates to foods via extracts of vegetables such as
spinach or celery should be considered an additive use, and not a food use
(i.e. the extract is being added for preservation as it contains a standardised
level of nitrate) and consequently such use would not be permitted by
Directive 95/2/EC as these extracts have not been approved as preservatives.